NCT01942122 is a Phase 2/Phase 3 clinical trial of DLBS1442 100 in Endometrioma, sponsored by Dexa Medica Group.

Who is sponsoring NCT01942122?

NCT01942122 is sponsored by Dexa Medica Group.

What drugs are being tested in NCT01942122?

Interventions in NCT01942122: DLBS1442 100, Mefenamic acid, DLBS1442 200.

What condition does NCT01942122 study?

NCT01942122 studies Endometrioma, Visual Analogue Pain Scale: Moderate or Severe Pain.

Is NCT01942122 still recruiting?

NCT01942122 is currently completed. Last updated 26 January 2022.

Last reviewed 2022-01-26 · How we verify

NCT01942122

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Role of DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis

Completed Phase 2/Phase 3 Last updated 26 January 2022

What this trial tests

Phase 2/Phase 3 trial testing DLBS1442 100 in Endometrioma in 60 participants. Completed in 1 April 2021.

Timeline

1 October 2015

Primary endpoint
1 February 2021

1 April 2021

Quick facts

Lead sponsor	Dexa Medica Group
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	1 October 2015
Primary completion	1 February 2021
Estimated completion	1 April 2021
Sites	3 locations across Indonesia

Drugs / interventions tested

DLBS1442 100 — full drug profile →
Mefenamic acid — full drug profile →
DLBS1442 200 — full drug profile →

Conditions studied

Endometrioma — all drugs for Endometrioma →
Visual Analogue Pain Scale: Moderate or Severe Pain — all drugs for Visual Analogue Pain Scale: Moderate or Severe Pain →

Sponsor

Dexa Medica Group — full company profile →

Who can join

Adults 18 to 50, female only, with Endometrioma or Visual Analogue Pain Scale: Moderate or Severe Pain. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Reduction of intensity (VAS) of composite-pain
Time frame: Week 8
Reduction of the intensity of composite-pain (dysmenorrhea, dyspareunia, non-menstrual chronic pelvic pain, dysuria, dyschezia) as measured by Visual Analogue Scale (VAS).

Sponsor's own description

This is a 3-arm, prospective, randomized, double-blind, and controlled study of DLBS1442 for the treatment of pain in patients suspected endometriosis. It is hypothesized that the reduction of the composite-pain intensity (as measured by VAS) from baseline to the end of study (week 8th) resulting from administration of DLBS1442, regardless of the dosage regimen, is significantly greater than that of Control. In addition, the administration of DLBS1442 at higher dose also results in significantly greater reduction than that of DLBS1442 at lower dose and of Control.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Pharmaceuticals targeting signaling pathways of endometriosis as potential new medical treatment: A review.
Hung SW, Zhang R, Tan Z, Chung JPW, et al · · 2021 · cited 120× · PMID 33948974 · DOI 10.1002/med.21802
Endometriosis: current challenges in modeling a multifactorial disease of unknown etiology.
Malvezzi H, Marengo EB, Podgaec S, Piccinato CA. · · 2020 · cited 57× · PMID 32787880 · DOI 10.1186/s12967-020-02471-0
A Lifelong Impact on Endometriosis: Pathophysiology and Pharmacological Treatment.
Chen LH, Lo WC, Huang HY, Wu HM. · · 2023 · cited 43× · PMID 37108664 · DOI 10.3390/ijms24087503
Endometriosis and pain in the adolescent- striking early to limit suffering: A narrative review.
Sieberg CB, Lunde CE, Borsook D. · · 2020 · cited 29× · PMID 31862211 · DOI 10.1016/j.neubiorev.2019.12.004
The Hallmarks of Endometriosis.
Psilopatis I, Burghaus S, Au K, Hofbeck L, et al · · 2024 · cited 6× · PMID 38884026 · DOI 10.1055/a-2306-8759

Verify or expand the search:

Other recruiting trials for Endometrioma

Currently open trials in the same condition.

NCT06775769 — Endometrioma Sclerotherapy and Ovarian Preservation · NA · recruiting
NCT06847685 — Mechanisms of Uterine Fluid Absorption During Early Pregnancy ( ELF Study) · recruiting
NCT06955221 — Effect of Alcohol Sclerotherapy on Pelvic Pain and Quality of Life in Women With Ovarian Endometriosis · NA · recruiting
NCT05962775 — Ethanol Sclerotherapy Prior to ART · NA · recruiting
NCT05801523 — Laparoscopic Therapy of Endometrioma: Sclerotherapy vs Cystectomy in Patients With Unfinished Reproductive Plans · NA · recruiting

Other Dexa Medica Group trials

Trials by the same sponsor.

NCT07420491 — The Efficacy and Safety of Reconyl in Acute Cough Treatment · Phase 3 · completed
NCT06558071 — Supplementation of Galatonol 300 mg / Striatin 30 mg in Postpartum Lactating Mothers · Phase 3 · completed
NCT06510257 — Safety and Efficacy Reconyl for Cough With/Without Sore Throat · Phase 2 · completed
NCT06497439 — Efficacy and Safety of Silfamin for Common Cold · Phase 2 · completed
NCT06558006 — Safety and Efficacy Predimenol for Headache · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01942122 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dexa Medica Group
Last refreshed: 26 January 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01942122.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing